Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008856063947 Date of Approval: 11/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Handwashing with soap at critical times and home based water treatment
Official scientific title Clustered randomized control trial intervention on U5 children diarrhea hotspot areas in southwestern Ethiopia
Brief summary describing the background and objectives of the trial Globally under five children diarrhea(U5 diarrhea) remain a major public health threat with nearly 1.7 billion cases occurring annually in all age groups and the second for 578,000 deaths among children under five years in 2013 (Achieng & Foyeke, 2007; Asamoah etal., 2016). In the world, a child dies every 60 seconds of diarrhea, six million children who do not live beyond the age of five years (UNICEF, 2016) due to several determinants (Genser et al., 2008). Globally, 90% of U5 diarrhea has been linked to poor water, sanitation, and hygiene provision, mainly about 88% of deaths was occurred in developing countries (Bill & Foundation, 2017). U5 diarrhea remains a major public health problem in East African nations(Shirley et al,. 2013), particularly in Ethiopia the prevalence accounts about 22.6% in the different regions with a median of 45%(Bambrick et al., 2015). Similarly, in northwest parts of Ethiopia, annual incidence rate during the study period was 155.3 per 1,000 populations at risk with variation greatly across the study districts(Azage, Kumie, Worku, & Bagtzoglou, 2015).The study conducted in sheko district, Bench Maji Zone, southwest Ethiopia indicated that socio economic and environmental factors contributed U5 diarrhea(Gebru et al., 2014). The prevalence of U5 diarrhea in Bench Maji Zone were 18.3 %, that is affected by individual and community level factors mainly not washing hands during critical times were 4.6 times risky for U5 diarrhea (Alemayehu, et al., 2020). The objective of this study is to evaluate the effectiveness of hand washing with soap at six critical time and home based for water treatment to reduce U5 diarrhea in southwestern Ethiopia from May to October 30/ 2020
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Under five children diarrhea
Purpose of the trial Providing handwashing soap and home based water treatment in combating childhood diarrhea
Anticipated trial start date 01/05/2020
Actual trial start date 01/05/2020
Anticipated date of last follow up 30/10/2020
Actual Last follow-up date 30/10/2020
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants) 720
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Providing handwashing soap two bars of handwashing soap per month Six months Intervention approaches Interventions will be given after preparing a protocol of activity designed to prevent diarrhea at the HH level. The intervention activity will be a key message that will be distributed by delegated field workers to eligible HHs every week for the next four months following a practical demonstration and delivering key health message at individual HH level. After an active demonstration, plain soap and Wuha agar will be provided for assign eligible HHs. Impression materials (leaflets) will be prepared with key message in Amharic states critical HW time and amount of chlorine solution for water treatment. There will be pictorial representation of the critical time and water treatment for those unable to read printing materials. The message will be enforced every week of stay, and the families will be supplied with one bar soap and Wuha agar for respective house hold. While, there is no intervention for the control groups to minimize the incidence of diarrhea. The field workers will collect, record the incidence, manage the case for the consecutive four months, and report every two weeks. Intervention description Hand washing with soap and water Treatment A: Hand washing with soap at six critical times only Handwashing messages 1. Wash your hands with given soap before meal preparation 2. Wash your hands with given soap before eating food 3. Wash your hands with a given soap after child washing 4. Wash your children’s hands with the soap (provided) after defecation 5. wash your hands with given soap after toilet use 6. wash your hand with given soap after contact any dirty materials Repeat the above six key messages through demonstration Provide the clusters or HH the plain soap with strict recommendation to use for only hand washing at six critical times. 180
Experimental Group Home based water treatment One cup of Wuha Agar in to twenty liter (Jerican) of raw drinking water six months 1. Add one cup of Wuha Agar in to twenty liter (Jerican) of raw drinking water 2. Shake well the jerican 3. Drink the water at least after thirty (30) minutes of treatment 4. Never drink before 30 minutes 5. Collect all bottles after you have completely finished the chemical used for treatment 6. Never share the Wuha Agar with any other households 180
Experimental Group Providing handwashing soap and home based water treatment Two bars of handwashing soap per month and one bottle of Wuha Agar per month six months For those households reviving both soap and wuha agar for home based water treatment, the intervention approaches will be as follow 1 Wash your hands with given soap before meal preparation 2. Wash your hands with given soap before eating food 3. Wash your hands with a given soap after child washing 4. Wash your children’s hands with the soap (provided) after defecation 5. wash your hands with given soap after toilet use 6. wash your hand with given soap after contact any dirty materials In addition, at similar time in the same households, water treatment approach will be as follows 1. Add one cup of Wuha Agar in to twenty liter (Jerican) of raw drinking water 2. Shake well the jerican 3. Drink the water at least after thirty (30) minutes of treatment 4. Never drink before 30 minutes 5. Collect all bottles after you have completely finished the chemical used for treatment 6. Never share the Wuha Agar with any other households 180
Control Group No any intervention 0 six months follow up No any treatment 180 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. At least one child aged 0–59 months living in the home 2. Not being a model household,(households that successfully implement all 16 packages of the Health Extension Program (HEP) are officially certified as a Model Health Extension Household. 3. Mothers/caregivers of under-five children living in the study area for at least four months and have no plan of migrating during the study period. 4. The children will be exclude, when they are seriously sick by other disease at the time of study and will be referred to near health facility 5. The communities using only untreated drinking-water sources 6. Unavailability of drinking water-quality management and diarrhea interventions programs in the community Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2020 Jimma University Institute of Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Jimma University Jimma 0378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Episodes of under five children diarrhea Two weeks of under five children diarrhea episodes
Secondary Outcome water quality Two weeks of water quality status
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
North Bench district Health office North Bench Birr town 0378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The International Institute for Primary Health Care Gulelle Sub City Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute for primary health care Addis Abeba Gulelle subsity Ethiopia Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bezuayehu Alemayehu bezua@ymail.com +251471111450 Jimma
City Postal code Country Position/Affiliation
Jimma town 0378 Ethiopia PhD student at Jimma University
Role Name Email Phone Street address
Scientific Enquiries Argaw Ambelu aambelu@yahoo.com +251911826218 Jimma
City Postal code Country Position/Affiliation
Jimma town 0378 Ethiopia Professor
Role Name Email Phone Street address
Scientific Enquiries Birhanu Teshome Ayele bayele@sun.ac.za +27218089111 Cape Town, Western Cape, ZA
City Postal code Country Position/Affiliation
Cape Town 0241 South Africa Senior Biostatistician Stellenbosch University Faculty of Medicine and Health Sciences
Role Name Email Phone Street address
Public Enquiries Higmengsit Astatek higemengist2010@gmail.com +25191190496 Jimma
City Postal code Country Position/Affiliation
Jimma town 0378 Ethiopia staff member
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared after completion of the study that will be organized on SPSS software. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The period of IPD sharing time will be six months. IPD will be available to principal through official request and or we will try it to be open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information